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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04874662
Other study ID # 20.07.CLI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2021
Est. completion date May 24, 2022

Study information

Verified date November 2021
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assessment of safety and efficacy of NAM/B6 oral administration on the amplification and commitment of satellite cells after a muscle injury


Description:

NAM/B6 oral administration after a muscle injury ("Satellite-01 study"): Effect on satellite cells as measured by immunofluorescence (Pax7 and myogenin antibodies to detect amplifying and committed satellite cells, respectively) on sections of muscle biopsies from the stimulated leg (leg 2) by muscle biopsies, comparing the study intervention (NAM/B6) to the control intervention (placebo)


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 24, 2022
Est. primary completion date May 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: 1. Males aged =18 = 50 years; 2. Subjects must be in good general health, as determined by the investigator or delegate, based on a comprehensive medical evaluation at screening including detailed medical history, full physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram (ECG) and clinical laboratory tests; 3. Body mass index (BMI) between18.5 and 24.9 kg/m2; 4. Normal dietary habits; 5. Willing to adhere to the prohibitions and restrictions specified in the protocol; 6. Must understand the nature of the study and be capable of giving written informed consent and be willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use. Exclusion Criteria: 1. Subjects presenting with the following blood pressure (BP) and heart rate (HR) values at the screening visit after 10 minutes in supine position: 1. 95 mmHg = systolic blood pressure (SBP) = 140 mmHg, 2. 50 mmHg = diastolic blood pressure (DBP) = 95 mmHg, 3. 50 bpm < HR < 80 bpm, 4. Or any other out of expected range values considered clinically significant by the investigator; 2. Screening visit 12-lead ECG values which are: 1. 120 < PR segment < 220 ms, 2. QRS complex < 120 ms, 3. QTcf < 430 ms, 4. Sign of any trouble of sinusal automatism, 5. Or any other ECG finding considered clinically significant by the investigator; 3. Have any clinically significant abnormalities in serum chemistry, hematology, or urinalysis at screening as judged by the investigator or delegate; 4. Active smokers; 5. Vegetarians or vegans; 6. Performed structured exercises within 3 months prior to participation in the study; 7. History or current use of anabolic steroids and/or growth hormone; 8. Use of corticosteroids within 3 months prior to participation in the study; 9. Current use of anticoagulant or anti-aggreging agents; 10. History or current use since 2 weeks before inclusion of any of the prohibited medications as detailed in Section 6.6.2; 11. History or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, musculoskeletal, psychiatric, systemic or infectious disease; 12. History or current use of drugs or alcohol (alcohol consumption > 40 grams/day); 13. Known intolerance to foods containing the ingredients under investigation; 14. Knee pain that prevents application of the electrical muscle stimulation protocol; 15. Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development; 16. Subjects under administrative or legal supervision; 17. Have participated in a clinical study in the last 3 months and received compensation beyond a certain approved and predefined limit.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
NAM/B6
Single daily dose administration will take place from Day 0 (V1) to Day 8 (V4) around 8 am after an overnight fast from the subsequent evening at 9 pm.

Locations

Country Name City State
Denmark Bisepjerg-Frederiksbjerg Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary immunofluorescence measurement Number of satellite cells as measured by immunofluorescence (Pax7 and myogenin antibodies to detect amplifying and committed satellite cells, respectively) on sections of muscle biopsies from the stimulated leg (leg 2) at day 4 and day 8 (muscle biopsies: MB3 and MB5), comparing the study intervention (NAM/B6) to the control intervention (placebo) 9 days
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